Article 44.  Compulsory Insurance of Life and Health of the Patient Involved in Clinical Trial of Medicinal Product for Medical Use

1. The institution which has obtained a permit for organization of a clinical trial of a medicinal product for medical use shall insure the life and health of the patient involved in a clinical trial of a medicinal product at its own expense as an insurant by making a contract for compulsory insurance .

2. The object of compulsory insurance shall be the patient’s property interest connected with harm caused to the patient’s life or health as a result of a clinical trial of a medicinal product for medical use.

3. An insurance event under a compulsory insurance contract shall be the patient’s death or health impairment, including health impairment entailing disability in case of a cause-and-effect relationship between the occurring events and participation of this present in clinical trial of medicinal product.

4. Claims for compensation of harm caused to the patient’s life or health shall be satisfied within the limitation period established by the civil legislation.

5. The extent of benefits under a compulsory insurance contract shall be as follows:

1) in case of patient’s death - RUR Two million for each patient who participated in the clinical trial of the medicinal product;
2) in case of patient’s health impairment:

a) which caused first class disability - RUR One million five hundred thousand for each patient involved in clinical trial of a medicinal product;
b) which caused second class disability - one million roubles for each patient involved in clinical trials of a medicinal product;
c) which caused third class disability - RUR Five hundred thousand for each patient involved in clinical trials of a medicinal product;
d) which did not cause disability - not more than RUR Three hundred thousand for each patient involved in clinical trial of a medicinal product.

6. The extent of benefits may be increased by a court decision.

7. The term of a compulsory insurance contract shall not be less than the term of the clinical trial of a medicinal product.

8. Terms and conditions of contract of compulsory insurance, including insurance rates of compulsory insurance, the list of documents required to enable payment of benefits, the procedure of individual identification code of a patient, the procedure of informing the insurer by the insurant of the number of patients involved in clinical trial of the medicinal product for medical use, the procedure for the payment of the insurance premium, the procedure for exercising the parties' rights and obligations prescribed by by this Federal Law and other federal laws under the contract of compulsory insurance shall be established by standard rules for compulsory insurance.

9. If harm is caused to the life of a patient involved in clinical trials of a medicinal product, the beneficiary under the compulsory insurance contract shall be people entitled to compensation for harm in the event of death of the breadwinner in accordance with the civil legislation; if there are no such people, the beneficiary will be the parents, spouse, children of the deceased patient involved in clinical trials of the medicinal product; if the deceased patient involved in clinical trials of a medicinal product had been dependent, the beneficiary will be people on whom he/she depended; compensation for funeral expenses on the patient involved in clinical trials of a medicinal product will be paid to the person who has incurred such expenses.

10. Benefits for compensation of harm caused to the life of a patient involved in clinical trials of a medicinal product shall be distributed among the beneficiaries in proportion to their number in equal shares.

11. In case of an insurance event with the patient involved in clinical trial of a medicinal product, the beneficiary shall have the right to claim immediately to the insurer for compensation of the harm caused. The insurer shall pay benefits within thirty days on receipt of the appropriate documents. The patient involved in clinical trial of a medicinal product or the beneficiary shall be obliged to provide the insurer with the patient's identification code required to enable payment of benefits, established by the insurer in accordance to the standard rules for compulsory insurance.

12. Until the extent of harm to be indemnified is determined in full, the insurer may, on request of the patient involved in clinical trials of a medicinal product, or on request of the beneficiary, pay part of the insurance benefits corresponding to the actually determined part of the harm caused.

13. Benefits under the compulsory insurance contract shall be paid irrespective of any benefits payable on any other type of insurance.

14. The participation of a patient in a clinical trial of medicinal product without the contract of compulsory insurance shall be prohibited.

15. The federal executive body issuing permits to conduct clinical trials of a medicinal product for medical use shall control to make sure the institution, which has obtained a permit to conduct clinical trials of a medicinal product, for medical, fulfills its obligation on compulsory life and health insurance of a patient involved in clinical trials of medicinal product for medical use as stated in this Article. (as amended by Federal Law of November 29, 2010, No. 313-FZ)

Table of contents

Chapter 1. General Provisions (articles 1-4)
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines (articles 5-6)
Chapter 3. State Pharmacopeia (article 7)
Chapter 4. State Control over Circulation of Medicines (articles 8-9)
Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use (articles 10-12)
Chapter 6. Performance of State Registration of Medicinal Products (articles 13-37)
Chapter 7. Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials (articles 38-44)
Chapter 8. Manufacture and Marking of Medicines (articles 45-46)
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation (articles 47-51)
Chapter 10. Pharmaceutical Activity (articles 52-58)
Chapter 11. Destruction of Medicines (article 59)
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use (articles 60-63)
Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation (articles 64-66)
Chapter 14. Information on Medicinal Products (article 67)
Chapter 15. Liability for Violation of Legislation of the Russian Federation for Medicines Circulation and Compensation for Harm to Human Health Caused by Administration of Med (articles 68-69)
Chapter 16. Final Provisions (articles 70-71)